CMS Issues Additional Sunshine Act Guidance With Respect to Payments to Speakers at Continuing Medical Education Events
In a final rule published in the Federal Register on November 13, 2014, the Centers for Medicare and Medicaid Services (CMS) eliminated the federal Sunshine Act reporting exclusion for payments to physicians at continuing medical education events. There now appears be some controversy with respect to this issue due to supplementary CMS guidance posted online.
In December, 2014, Sunshine Act guidance material posted by CMS (here) states that there may be circumstances in which applicable manufacturers will be required to report indirect payments to physicians for continuing medical education events. This appears to contradict the regulatory language and preamble discussion included in the November 13 final rule.
The December CMS guidance is the most recent interpretation of the reporting of payments to physicians for continuing medical education events pursuant to the Sunshine Act. In the published final rule, CMS stated that one of the reasons it was deleting the continuing medical education speaker exclusion was because it was “redundant” with another exemption for indirect payments to a physician when the applicable manufacturer does not know the recipient of the funds. CMS stated in the preamble to the final rule, “When an applicable manufacturer or applicable GPO provides funding to a continuing education provider, but does not either select or pay the covered recipient speaker directly, or provide the continuing education provider with a distinct, identifiable set of covered recipients to be considered as speakers for the continuing education program, CMS will consider those payments to be excluded [under the indirect payments exclusion].” (79 FR 67759).
The new CMS guidance materials suggest there may be circumstances when these indirect transfers are reportable under the Sunshine Act. Specifically, CMS states on its Law and Policy web page that, “Starting in 2016, when an applicable manufacturer provides an indirect payment or other transfer of value to a continuing education organization for a continuing education event to physicians, and knows or finds out the identity of the physician attendees/speakers within the reporting year or by the end of the second quarter of the following reporting year, that payment must be reported to CMS in 2017” (emphasis in the original).
The apparent contradiction between the CMS final rule and the recent CMS Policy and Law web page pronouncement is likely to require additional clarification from CMS. Applicable manufacturers and physicians should continue to monitor CMS announcements and direction regarding this issue. Manufacturers will need to abide by reporting and disclosure requirements and affected physicians will want to know in advance if their participation in a continuing medical education event will ultimately be reportable as part of the Sunshine Act implementation.
Saul Ewing attorneys have been following and will continue to monitor the changes with respect to the continuing medical education exemption and the implementation of the Sunshine Act. Previous Saul Ewing articles on the Sunshine Act may be found here. For more information on these matters, please contact the authors or the attorney at the firm with whom you are regularly in contact.